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TMS for Post Stroke Depression

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ClinicalTrials.gov Identifier: NCT04093843
Recruitment Status : Recruiting
First Posted : September 18, 2019
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Amelia Adcock, West Virginia University

Brief Summary:
The purpose of this study is to find alternative treatments for patient's suffering from depression after having a stroke.This study aims to show that accelerated rTMS is a safe, effective,and convenient treatment for patient's suffering from post-stroke depression in the acute to subacute phase. This will be an open label trial and thus all participants will receive the active rTMS intervention.

Condition or disease Intervention/treatment Phase
Post-stroke Depression Device: TMS Not Applicable

Detailed Description:

The primary objectives of this project are as follows:

  1. To assess the efficacy TMS in PSD. We hypothesize that there will be a decrease in the HAMD score in patients receiving TMS
  2. To assess the feasibility of an accelerated protocol using rTMS in patients with acute to subacute stroke and co-existing PSD. We hypothesize that the accelerated protocol will promote compliance in our patient population and that the administration of this intervention is feasible.
  3. To assess the safety of rTMS in patients with acute to subacute stroke. We hypothesize that the side effects of TMS will be minimal and the therapy will be well-tolerated and safe in individuals with recent strokes and co-existing PSD.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Open label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Accelerated rTMS as a Treatment for Post-stroke Depression in the Subacute Phase: an Open Label Pilot Study
Actual Study Start Date : October 24, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Open label
Open label single arm study to determine safety and effectiveness of TMS for post stroke depression
Device: TMS
NeuroStar TMS Therapy




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: After Day 1 of rTMS treatment ]
  2. Adverse Events [ Time Frame: After Day 2 of rTMS treatment ]
  3. Adverse Events [ Time Frame: After Day 3 of rTMS treatment ]
  4. Adverse Events [ Time Frame: After Day 4 of rTMS treatment ]
  5. Adverse Events [ Time Frame: 3 months following neurostimulation ]
  6. Adverse Events [ Time Frame: 6 months following neurostimulation ]
  7. Adverse Events [ Time Frame: 12 months following neurostimulation ]
  8. Improvement on depressive symptoms as rated by the Hamilton Depression Rating Scale (7 or below in normal; 23 and above correlates with very severe depression) [ Time Frame: Depressive symptoms will be quantified before the rTMS stimulation protocol ]
  9. Improvement on depressive symptoms as rated by the Hamilton Depression Rating Scale (7 or below in normal; 23 and above correlates with very severe depression) [ Time Frame: Depressive symptoms will be quantified immediately after the 4 days of rTMS stimulation. ]
  10. Improvement on depressive symptoms as rated by the Hamilton Depression Rating Scale (7 or below in normal; 23 and above correlates with very severe depression) [ Time Frame: Depressive symptoms will be quantified 3 months after completion of the rTMS stimulation protocol. ]
  11. Improvement on depressive symptoms as rated by the Hamilton Depression Rating Scale (7 or below in normal; 23 and above correlates with very severe depression) [ Time Frame: Depressive symptoms will be quantified 6 months after completion of the rTMS stimulation protocol. ]
  12. Improvement on depressive symptoms as rated by the Hamilton Depression Rating Scale (7 or below in normal; 23 and above correlates with very severe depression) [ Time Frame: Depressive symptoms will be quantified 12 months after completion of the rTMS stimulation protocol. ]


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Ages Eligible for Study:   22 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Between the ages of 22-85 years old
  • Radiographic evidence of acute or subacute stroke
  • Ischemic stroke diagnosed within the last 2 weeks to 6 months
  • HAMD depression score 8 or greater
  • Able to provide written informed consent
  • Agree to participate in all study procedures

Exclusion Criteria:

  • Metallic objects or neurostimulators implanted intracranially
  • Stroke in the area of stimulation
  • Current thoughts of SI or self-harm as assessed by the M.I.N.I. Suicide Scale score > 8
  • ASRM (Altman Self Rating Mania Scale) score > 6 (6 or above indicates likelihood of manic symptoms)
  • Current use of illicit substances
  • Known history of epilepsy or seizure disorder
  • Clinically significant EKG abnormalities including QTC prolongation >450 ms in men or >480 ms in women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04093843


Contacts
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Contact: Amelia Adcock, MD (304) 293-3527 akadcock@hsc.wvu.edu

Locations
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United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Amelia Adcock

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Responsible Party: Amelia Adcock, Associate professor, West Virginia University
ClinicalTrials.gov Identifier: NCT04093843     History of Changes
Other Study ID Numbers: 1804090922
First Posted: September 18, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Stroke
Depression
Depressive Disorder
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders